Yoga for Patients With Irritable Bowel Syndrome

May 23, 2017 updated by: Dania Schumann, Universität Duisburg-Essen

Randomized Controlled Trial on Yoga for Irritable Bowel Syndrome

The proposed study aims to investigate the feasibility, effectiveness, and perceived benefit of a hatha yoga intervention for patients with irritable bowel syndrome (IBS) compared to nutrition counselling. Further, the potential of both interventions to influence the gut microbiome will be inquired.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Essen, Germany, 45276
        • Universität Duisburg-Essen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with irritable bowel syndrome (IBS) diagnosed by physician and confirmed by Rome III diagnostic criteria

Exclusion Criteria:

  • inflammatory bowel diseases (IBD)
  • total abdominal colectomy
  • no sonographie or colonoscopy as diagnostic criterion
  • stool lactoferrin > 7mg/g
  • pregnancy or breast feeding
  • simultaneous participation in further clinical intervention trials
  • Regular yoga practice or nutrition counselling in the past 12 months
  • Planned surgery in the study period
  • Serious illness that would interfere with the ability to practice yoga

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Yoga
12 week yoga course, two times a week 75 minutes each time
Behavioral: Yoga
Yoga intervention 12 weeks, twice weekly 75-minute intervention Yoga postures, breathing, relaxation, and meditation
Active Comparator: Nutrition
3 counselling sessions within 12 weeks
Behavioral: Nutrition Counselling
Evidence-based Nutrition Counselling, 3 appointments within 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Irritable Bowel Syndrome Symptoms
Time Frame: Week 12
Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease specific quality of life
Time Frame: Week 12
Irritable Bowel Syndrome Quality of Life measurement (IBS-QOL)
Week 12
disease specific quality of life
Time Frame: Week 24
Irritable Bowel Syndrome Quality of Life measurement (IBS-QOL)
Week 24
Generic Health-related Quality of life
Time Frame: Week 12
Short Form 36 Health Survey Questionnaire, SF-36
Week 12
Generic Health-related Quality of life
Time Frame: Week 24
Short Form 36 Health Survey Questionnaire, SF-36
Week 24
Emotional distress
Time Frame: Week 12
Hospital Anxiety and Depression Scale (HADS)
Week 12
Emotional distress
Time Frame: Week 24
Hospital Anxiety and Depression Scale (HADS)
Week 24
Subjective Stress
Time Frame: Week 12
Cohen Perceived Stress Scale (CPSS)
Week 12
Subjective Stress
Time Frame: Week 24
Cohen Perceived Stress Scale (CPSS)
Week 24
Subjective improvement of symptoms
Time Frame: Week 12
Adequate Relief Score and Global Improvement Scale (GI)
Week 12
Subjective improvement of symptoms
Time Frame: Week 24
Adequate Relief Score and Global Improvement Scale (GI)
Week 24
Gut microbiome
Time Frame: Week 12
Stool samples
Week 12
Adverse Event
Time Frame: Week 12
Week 12
Adverse Event
Time Frame: Week 24
Week 24
Irritable Bowel Syndrome Symptoms
Time Frame: Week 24
Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universität Duisburg-Essen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

March 17, 2016

First Submitted That Met QC Criteria

March 22, 2016

First Posted (Estimate)

March 29, 2016

Study Record Updates

Last Update Posted (Actual)

May 24, 2017

Last Update Submitted That Met QC Criteria

May 23, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-6653-BO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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